Regulatory affairs

• WEBINAR ARCHIVE: Five-Part Labeling Series - Part 2: Safety Information in the EU: Summary of Product Characteristics
  Emne: Regulatory affairs, Product information, Labelling, EU regulation, Europe
  Udbyder: DIA
  Sted: Internet
  Dato: until 16 March 2012
  
• ARCHIVED WEBINAR: Five-part Labeling Series - Part 3: US Prescribing Information - Writing the Highlights
  Emne: Regulatory affairs, Product information, Labelling, US regulation, USA, Product information
  Udbyder: DIA
  Sted: Internet
  Dato: until 24 March 2012
  
• ARCHIVED WEBINAR: Source Documentation, Audit Trails and EDC, How Do They Fit Together?
  Emne: Regulatory affairs, Documentation, US regulation, Handling, Clinical documentation, USA, FDA
  Udbyder: DIA
  Sted: Internet
  Dato: until 24 May 2012
  
• Archived Webinar - Two-part Series: What You Need to Know about FDA’s Drug Listing and Import Process: Part 1- Drug Listing/Regulatory Perspective
  Emne: Regulatory affairs, USA, FDA, Procedures / Rutines
  Udbyder: DIA
  Sted: Internet
  Dato: until 12 July 2012
  
• Introduction to Japanese Institutions and Regulatory Authorities
  Emne: Regulatory affairs, Japan, Procedures / Rutines, Management
  Udbyder: DIA
  Sted: Internet
  Dato: Any time
  
• Regulatory Issues
  Emne: Regulatory affairs, USA, FDA, Procedures / Rutines
  Udbyder: DIA
  Sted: Internet
  Dato: Any time
  
• Pharmacovigilance and Risk Management Strategies 2012
  Emne: Regulatory affairs, Japan, Europe, USA, Market, Strategy
  Udbyder: DIA
  Sted: Arlington, VA, USA
  Dato: 23-25 January 2012
  
• Training course on Excellence in Pharmacovigilance: Clinical Trials and Post Marketing
  Emne: Regulatory affairs, Market, Strategy
  Udbyder: DIA
  Sted: London, England
  Dato: 13-17 February 2012
  
• Extended EudraVigilance Medicinal Product Dictionary training course
  Emne: Regulatory affairs, Europe, EMEA, Procedures / Rutines
  Udbyder: DIA
  Sted: London, England
  Dato: 14-15 February 2012
  
• Extended EudraVigilance Medicinal Product Dictionary training course
  Emne: Regulatory affairs, Europe, Procedures / Rutines, EMEA
  Udbyder: DIA
  Sted: London, England
  Dato: 20-21 March 2012
  
• EudraVigilance training - Electronic Reporting of ICSRs in the EEA
  Emne: Regulatory affairs, Europe, ICH, Management
  Udbyder: DIA
  Sted: London, England
  Dato: 18-20 April 2012
  
• The New Individual Case Safety Report (ICSR) International Standard and ICH E2B/M2 Information Day
  Emne: Regulatory affairs, Europe, ICH, Registration procedures
  Udbyder: DIA
  Sted: London, England
  Dato: 4 May 2012
  
• The New Individual Case Safety Report (ICSR) International Standard and ICH E2B/M2 Information Day (3rd)
  Emne: Regulatory affairs, Europe, ICH
  Udbyder: DIA
  Sted: London, England
  Dato: 4 May 2012
  
• EudraVigilance training - Electronic Reporting of ICSRs in the EEA
  Emne: Regulatory affairs, Europe, ICH, Management
  Udbyder: DIA
  Sted: London, England
  Dato: 21-23 May 2012
  
• 1st CMC Forum in Japan: Challenges for Quality Improvement in Asia
  Emne: Regulatory affairs, Japan, Procedures / Rutines
  Udbyder: DIA
  Sted: Tokyo, Japan
  Dato: 11 June 2012
  
• EudraVigilance training - Electronic Reporting of ICSRs in the EEA
  Emne: Regulatory affairs, Europe, Management, ICH
  Udbyder: DIA
  Sted: London, England
  Dato: 10-12 September 2012
  
• Drug Regulatory Affairs in Drug Development
  Emne: Regulatory affairs, Abbreviated applications, EU regulation, Documentation, EU regulation, Europe, CTD, Registration file, Registration procedures, Scientific Advice
  Udbyder: KU, FARMA
  Sted: Copenhagen, Denmark
  Dato: 1-5 October 2012
  
• DIA Non-Clinical Safety Sciences and Their Regulatory Aspects Training Course
  Emne: Regulatory affairs, Europe, Procedures / Rutines, ICH
  Udbyder: DIA
  Sted: Lisbon, Portugal
  Dato: 19-23 November 2012
  
• EudraVigilance training - Electronic Reporting of ICSRs in the EEA
  Emne: Regulatory affairs, Europe, Management, ICH
  Udbyder: DIA
  Sted: London, England
  Dato: 3-5 December 2012
  

Courses from other providers

• Medical Device Approval Process
  Emne: Regulatory affairs, Product information, Devices
  Udbyder: Barnett International
  Sted: San Diego, CA, USA
  Dato: 27-28 February 2012
  
• Introduction to FDA
  Emne: Regulatory affairs, USA, Procedures / Rutines, FDA
  Udbyder: Barnett International
  Sted: Philadelphia, PA, USA
  Dato: 8-9 March 2012
  
• Source Documentation
  Emne: Regulatory affairs, Clinical documentation, Development, Guidelines
  Udbyder: Barnett International
  Sted: Boston, MA, USA
  Dato: 09 March 2012
  
• Preparing IND Submissions
  Emne: Regulatory affairs, USA, FDA, Procedures / Rutines, Market, Product development
  Udbyder: Barnett International
  Sted: San Fransisco, CA, USA
  Dato: 15-16 March 2012
  
• Interfacing Chemistry with Patents
  Emne: Regulatory affairs, Market, Interlectual property rights
  Udbyder: Scientific Update
  Sted: Barcelona, Spain
  Dato: 20-21 March 2012
  
• Medical Device Quality Systems: How to Comply with Global Regulations
  Emne: Regulatory affairs, Devices, Development, Regulatory management
  Udbyder: CfPA
  Sted: Amsterdam, The Netherlands
  Dato: 26-27 March 2012
  
• Preparing Compliant eCTD Submissions
  Emne: Regulatory affairs, Europe, Procedures / Rutines, Procedures/Rutines, Clinical documentation, Guidelines, CTD, USA, CTD, Procedures / Rutines, FDA
  Udbyder: RAPS
  Sted: Rockville, MD, USA
  Dato: 28-29 March 2012
  
• Global IND Submissions
  Emne: Regulatory affairs, Procedures/Rutines, Documentation, CTD-format
  Udbyder: Barnett International
  Sted: San Fransisco, CA, USA
  Dato: 12-13 April 2012
  
• Complying with QS Regulation Requirement
  Emne: Regulatory affairs, USA, QA, FDA
  Udbyder: Barnett International
  Sted: San Fransisco
  Dato: 30 April 2012
  
• Introductory Course
  Emne: Regulatory affairs, Abbreviated applications, International regulation, EU regulation, Europe
  Udbyder: TOPRA
  Sted: Dorking, UK
  Dato: 30 April - 4 May 2012
  
• Conducting Clinical Trials Under ICH GCP
  Emne: Regulatory affairs, Clinical trials, EU regulation, Europe, ICH
  Udbyder: Barnett International
  Sted: Boston, MA, USA
  Dato: 3-4 May 2012
  
• FDA Meetings 101
  Emne: Regulatory affairs, USA, FDA, Procedures / Rutines
  Udbyder: Barnett International
  Sted: Philadelphia, PA, USA
  Dato: 10 May 2012
  
• Drug Approval Process
  Emne: Regulatory affairs, USA, CTD, FDA
  Udbyder: Barnett International
  Sted: Philadelphia, PA, USA
  Dato: 14-15 June 2012
  
• How to Prepare and Submit a Bullet Proof 510(k)
  Emne: Regulatory affairs, USA, FDA, Devices, Regulatory management
  Udbyder: Barnett International
  Sted: Philadelphia, PA, USA
  Dato: 20 June 2012
  
• European GMPs and the Role of the QP
  Emne: Regulatory affairs, Europe, QP
  Udbyder: ECA
  Sted: Bethesda, MD, USA
  Dato: 27-28 June 2012
  
• CT10: The IND: How to gain approval for clinical trials in the USA
  Emne: Regulatory affairs, Clinical trials, Application, International regulation, Clinical development, Clinical trials, International regulation, Regulation
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Good Clinical Practices (GCPs)
  Emne: Regulatory affairs, Clinical trials, International regulation
  Udbyder: RAPS
  Sted: Internet
  Dato: Ongoing
  
• SUB11: The Decentralised Procedure (DCP)
  Emne: Regulatory affairs, Europe, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Electronic Common Technical Document (eCTD)
  Emne: Regulatory affairs, Japan, CTD, Europe, CTD, Registration file, USA, CTD
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Essentials of EU and US Regulatory Affairs for Human Products
  Emne: Regulatory affairs, Europe, Registration procedures, Procedures / Rutines, USA, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• EU Variation Procedure
  Emne: Regulatory affairs, Maintenance, Variations, EU regulation
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Orphan Drug Applications in the EU and USA
  Emne: Regulatory affairs, Europe, Orphan drugs, USA, Orphan drugs, Procedures / Rutines, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Preparing Submission in the Common Technical Document (CTD) Format
  Emne: Regulatory affairs, Europe, Registration file, Japan, USA, CTD, Procedures / Rutines, Procedures / Rutines, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Registration of Monoclonal Antibodies
  Emne: Regulatory affairs, Biotech, Regulation, Europe, USA, Procedures / Rutines, Antibodies, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• SUB08: The ANDA: Requirements for obtaining FDA approval for a generic product in the USA
  Emne: Regulatory affairs, USA, Procedures / Rutines, CTD
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• SUB09: The NDA process: Requirements for obtaining approval for a new drug in the USA
  Emne: Regulatory affairs, USA, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• The European Centralised Procedure (CP)
  Emne: Regulatory affairs, Europe, Registration procedures
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• The Mutual Recognition Procedure (MRP)
  Emne: Regulatory affairs, Europe, Registration procedures
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing